Clinical Trials Expo 2006 Posters and Demonstrations Abstracts Sponsored by Clinical Trials

Clinical Trials Expo 2006 Posters and DemonstrationsAbstractsSponsored byClinical Trials Working Group American Medical Informatics AssociationMonday, November 13, 20065:15 p.m. – 7:00 p.m.Innovation and Information CenterHilton Washington & TowersWashington, DCAMIA Clinical Trials Expo 2006Categories of topics for CTExpo submissions (demonstrations or posters) •Clinical trial protocol authoring and management tools•Multi-center trial infrastructure•Practice-based research networks; Interoperability strategies (messaging, vocabularies, ontologies, etc.)•Recruitment for clinical research•Sharing clinical research data (clinical trial registries, etc)•User tools: collecting and storing data (usability, databases, etc)•Secondary use of clinical data for research (health services research, outcomes research)Members of the CTExpo Review CommitteeJudith R. Logan, MD, MS – ChairAssociate Professor, Department of Medical Informatics & Clinical EpidemiologyOregon Health & Science UniversityPeter Embi, MD, MS; Assistant Professor, General Internal MedicineUniversity of CincinnatiStan Kaufman, MD; President, EpimetricsPhilip R.O. Payne, M. Phil; PhD Candidate, Department of Biomedical Informatics;Columbia University2006 Officers of the AMIA Clinical Trials Working Group Charles E. Barr, MD, MPH, ChairTherapeutic Area Director, Roche Laboratories Inc.Stan Kaufman, MD, Chair-ElectPresident, EpimetricsJudith R. Logan, MD, MS, SecretaryAssociate Professor, Department of Medical Informatics & Clinical EpidemiologyOregon Health & Science UniversityTABLE OF CONTENTS1. Protocol Tracker – An open source toolkit for building Clinical Trials Management Systems (4)2. The Clinical Research Management System (5)3. Towards Semantic Interoperability in a Clinical Trials ManagementSystem (6)4. The World Health Organization's International Clinical Trials RegistryPlatform (7)5. The Trial Bank Project (8)6. CALAEGS: City of Hope Laboratory Adverse Event Grading System (9)7. Clinical research workflow in community practice settings and the role of Information Technology (10)8. OpenClinica 2.0 - Using Open Source in Clinical Research (11)9. Secondary Use of Health Data to Support Evidence-Based Study Design (12)10. A Contact Registry for Persons with Rare Diseases: A Tool for Recruitingand Retaining (13)11. An Infrastructure for Conducting Clinical Trials in Primary Care (14)12. Using Ontology Reasoning to Match Electronic Patient Records to Clinical Trials (15)13. A Web Database Facilitating Quality Improvement of Inpatient Glycemic Control (16)14. Automated Sharing of Workflows (17)15. The PEN is Mightier Than the Sword: Applications of Consumer Health Informatics to Patients with Autoimmune Diseases (18)1. Protocol Tracker – An open source toolkit for building Clinical TrialsManagement Systems.Presenter: Robert Dennis, Director, Computing Technologies Research LabOrganization: David Geffen School of Medicine, UCLAContact: rdennis@; phone: 310-206-2462; FAX: 310-267-5253Topics: Clinical trial protocol authoring and management tools; Multi-center trial infrastructure; User tools: collecting and storing dataOther authors: Khy Huang, Jeff Wang, Jianming He, Alan G. Robinson, M.D.ABSTRACTProtocol Tracker (pTracker) is a toolkit for building clinical trials management systems implemented within the OpenACS (Open Architecture Community System) framework. OpenACS is an open source web application framework. The OpenACS has a dedicated international community of users and contributors, and the software has been used as the basis of some of the busiest web sites.Our poster and demonstration will present pTracker in context of three specific current clinical trials: the Inter-SPORE Prostate Biomarker Study (IPBS), and two separate clinical trials within the Microbicide Development Program (MDP). IPBS is a prospective study involving all 11 NCI supported Prostate SPORE sites. A total of 700 newly diagnosed patients with prostate cancer will be recruited from across the 11 sites to provide tissue and blood samples prior to primary treatment and 5 years of follow-up information. MDP is a multi-project, multi-center collaborative program with the NIH (U-19) to develop an effective rectal microbicide. The context is HIV-AIDS prevention research. Two of the three projects within the MDP involve clinical trials. In addition, our poster will provide an overview of the same pTracker tools used to develop the patient management system supporting the California state-sponsored Improving Access, Counseling, and Treatment (IMPACT) for Californians with prostate cancer, and the Patient Reported Outcomes of Complimentary, Alternative, and Integrative Medicine (PROCAIM) system. PROCAIM is a self-registered longitudinal study focused on patients and the interactions with physicians in the general field of alternative, integrative and complimentary medicine.PTracker consists of three main components: a flexible (case report) form builder, a general workflow engine, and a subject management module. Our form builder is a mature question engine that supports complex page flow, logic, and reporting. The pTracker workflow engine is a customization of the basic finite state machine workflow package in the OpenACS. A workflow defines the states and the actions that move subjects through states (transitions). The subject manager is essentially a roster or registry of patients or objects associated to a study within pTracker. Subjects are what are moved through a workflow. Subjects are OpenACS objects. Normally subjects are human patients that move through a well-define workflow (i.e., a protocol). However, in the IPBS one workflow models the handling and inventory of biological specimens at each SPORE site, and so the objects are actually packages of tissues slides and serum vials from many patients that are periodically sent to a central pathology core for later distribution to the biomarker investigators. Support for the development of pTracker has come in part from Dr Alan G. Robinson’s Integrated Advanced Information Management Systems grant from the National Library of Medicine (NLM grant number G08-LM-7851).2. The Clinical Research Management SystemPresenter: Allen Tien, CEO and Research DirectorOrganization: Medical Decision Logic, Inc.Contact: allentien@, phone: 410-262-7869Topics: Clinical trial protocol authoring and management tools; Multi-center trial infrastructure; Interoperability strategies; Recruitment for clinical research; Sharing clinical research data; User tools: collecting and storing data; Secondary use of clinical data for researchOther authors: Steven Beales, Geoff Ott, Alexandra LoveABSTRACTThe Clinical Research Management System (CRMS) is a browser-based Web application with a rich, interactive, user-friendly interface based on Ajax. The CRMS data model builds upon CDISC, HL7 and caBIG models and standards. Developed with an iterative, user-centered design process, the CRMS closely matches research workflow processes and needs. The Subject Registry module handles many research administrative tasks, including eligibility assessment, consent tracking, enrollment, IRB documentation, and reporting. The Protocol Schema module provides a graphical interface and integrated domain specific language (DSL) for building an executable representation of protocol workflow; a dynamic temporal constraint logic engine supports adaptive scheduling. This module also tracks research procedures for billing compliance. The CRMS is easy to configure for a specific protocol. In testing, research staff implemented oncology clinical trial protocols in under eight hours. The CRMS has been deployed at 2 major university research hospitals. Ongoing development will address areas such as tissue banking, adverse events, case report forms, the protocol development process, budgeting, and most generally, knowledge representation, translation, and clinical integration.3. Towards Semantic Interoperability in a Clinical Trials ManagementSystemPresenter: Ravi Shankar, Research StaffOrganization: Stanford UniversityContact: rshankar@, phone: (650) 724-9933, FAX: (650) 725-7944Topics: Clinical trial protocol authoring and management tools; Interoperability strategies Other authors: Susana Martins, Martin O'Connor, Amar Das, Dave ParrishABSTRACTThe lifecycle management of a complex clinical trial typically involves multiple applications facilitating activities such as trial design specification, clinical sites management, laboratory management, and participants tracking. The lack of common nomenclature among the different sources of the tracking information and the unreliable nature of the data generation can lead to significant operational and maintenance challenges. The applications support different but related aspects of a clinical trial, and require clinical trial data flow and knowledge exchange between the applications. Thus, there is a strong impetus to integrate these diverse applications at syntactic, structural and semantic levels so as to improve clarity, consistency and correctness in specifying clinical trials, and in acquiring and analyzing clinical data.We present Epoch, a knowledge-based approach to support a suite of clinical trial management applications. We are adapting this approach to the Immune Tolerance Network (ITN; ), an international consortium that aims to accelerate the development of immune tolerance therapies through clinical trials and integrated mechanistic (biological) studies. The ITN is involved in planning, developing and conducting clinical trials in autoimmune diseases, islet, kidney and liver transplantation, allergy and asthma, and operates more than a dozen core facilities that conduct bioassay services. At the core of our framework is a suite of ontologies that conceptualizes the clinical trial domain. The ontologies along with semantic inferences and rules provide a common protocol definition for the applications to use to interoperate semantically. We use Protégé, a knowledge-acquisition tool, and emerging semantic technologies such as OWL and SWRL languages to build the Epoch ontologies and to encode ITN clinical trials using these ontologies. In this presentation, we will also illustrate the use of the Epoch framework in supporting the semantic interoperability of a subset of the clinical trial management applications to support specimen tracking.4. The World Health Organization's International Clinical Trials Registry Platform Presenter: Ida Sim, Project CoordinatorOrganization: World Health OrganizationContact: simi@who.int, phone: 415-502-4519, FAX: 415-476-7964Topic: Sharing clinical research dataOther authors: An-Wen Chan, Patrick Unterlerchner, Ghassan Karam, A. Metin Gulmezoglu, Tikki PangABSTRACTSelective reporting of clinical trial results is known to be widespread, and recent high-profile cases have demonstrated the potential impact of suppressing negative findings in healthcare. In order to restore public trust in clinical research, it is clear that transparency and accountability must be strengthened through trial registration and results reporting on public electronic databases.The World Health Organization (WHO) established the International Clinical Trials Registry Platform in August 2005 with the primary objective of ensuring that all clinical trials worldwide are uniquely identifiable through a system of public registers, and that a minimum set of results is made publicly available. This presentation will highlight the current policies and progress of the WHO Registry Platform, as well as outline the technical and practical challenges of implementing global trial registration.WHO Registry Platform policies apply to all research studies that prospectively assign humans to one or more interventions, regardless of study design or intervention type. For a trial to be considered fully registered, all 20 items in the WHO Trial Registration Data Set (Version 1.0) must be recorded in a national, regional, or international Primary Register that meets acceptable standards for content, technical capabilities, quality assurance, and administration. A WHO Search Portal to identify trials across Primary Registers will be developed to meet the needs of patients, scientists, and other healthcare workers. The WHO is now also defining a Minimum Trial Report, to be reported for every registered trial.Informatics challenges for the Registry Platform include the standardization of data fields and clinical vocabulary across international registers, the identification of duplicate registration entries and the assignment of a Universal Trial Reference Number (UTRN) to each globally unique trial, and the definition of a data interchange standard. The WHO is working with CDISC to define this interchange standard, and to test the standard with , PDQ, the Trial Bank Project, and several NIH NECTAR and CTSA projects.Finally, global compliance, oversight, and capacity building must be considered in WHO Registry Platform policies, which will be re-evaluated and refined periodically as the complex field of trial registration continues to evolve.5. The Trial Bank ProjectPresenter: Ida Sim, Associate ProfessorOrganization: University of California San FranciscoContact: ida.sim@, phone: 415-502-4519, FAX: 415-476-796Topics: Interoperability strategies; Sharing clinical research dataOther authors: Ben Olasov, Simona CariniABSTRACTRandomized controlled trials (RCTs) are a key source of evidence for medical practice. However, RCT results are published as text, which computers cannot read. Computers are therefore illiterate of the evidence they could help clinicians apply. The Trial Bank project captures over 160 unique information items about the design, execution, and results of RCTs into a structured knowledge base called RCT Bank.The Trial Bank Project encompasses work in several related grants that:1. extend the ontology of RCTs to include cluster-randomized trials, and a standard representation of eligibility rules2. work with funding agencies (VA, Canadian Institutes of Health Research) and journals (PLoS, BMJ) to capture trials into Trial Bank3. integrate trial registration and reporting into the Electronic Primary Care Research Network4. visualize and analyze HIV trials as a Driving Biological Project of the National Center for Biomedical OntologyBy capturing all the information needed for critically applying a trial to clinical care, Trial Bank explores and demonstrates the challenges and opportunities for an open-access, machine-understandable repository of RCT evidence for computer-assisted evidence-based medicine. The Trial Bank Project is the research foundation for AMIA's Global Trial Bank initiative on open data for clinical trial data reporting. It also incorporates and extends the trial registration and reporting recommendations of the WHO International Clinical Trials Registry Platform. This exhibit will access the trial-bank server at / to demonstrate: 1) Bank-a-Trial, a website for entering RCT design, execution and summary information into our trial bank with an integrated dynamic UMLS term selector; and 2) RCT Presenter, a website for searching and browsing trials in the trial bank.Items for discussion include standardization of data models for clinical trial activities, integration of RCT evidence into decision support tools at the point of care, and new models of electronic publication of science.6. CALAEGS: City of Hope Laboratory Adverse Event Grading SystemPresenter: Joyce Niland, Chair and Professor, Information SciencesOrganization: City of Hope National Medical CenterContact: jniland@, phone: 626 359-8111 x63032, FAX: 626 301-8802Topic: Clinical trial protocol authoring and management toolsOther authors: Doug Stahl, David Ko, Jennifer Neat, Jack Lee, Susan PannoniABSTRACTThe monitoring of adverse events (AEs) is a critical component of clinical trial management. The standard tool for AE grading in oncology is the Common Terminology Criteria for AE (CTCAE). A significant portion of the CTCAE grading is based on quantitative laboratory data. Under current practice, Clinical Research Associates (CRAs) transcribe laboratory results for clinical trials patients into a flowsheet, and then use these to interpret the AE grades. At City of Hope a system has been developed to automate the algorithms for grading of laboratory based AEs, greatly improving the efficiency and accuracy of detecting and assessing lab-based toxicities. This system, titled CALAEGS: City of Hope Laboratory Adverse Event Grading System, is now being ported to an open source version for distribution to any institution center requiring such decision support for AE grading.7. Clinical research workflow in community practice settings and the role of Information TechnologyPresenter: Sharib Khan, Project CoordinatorOrganization: Columbia UniversityContact: sharib.khan@, phone: 646-932-6757Topics: Practice-based research networksOther authors: Rita Kukafka, Philip RO Payne, Stephen B. Johnson, J Thomas Bigger ABSTRACTIntroduction: This pilot study was undertaken as part of the InterTrial Project to understand the clinical research workflow, the role of information technology (IT) in clinical research tasks and to identify barriers and attitudes of key stakeholders (research coordinators and principal investigators) towards increased IT adoption by community practices. The findings have informed the development of a web-based application to increase digitization of research data and processes and to improve clinical research information exchange. In addition, follow up studies are being conducted to develop a detailed workflow process models and a behavioral model to predict IT adoption by end users.Methods: Six community practices were selected for the study. Each was administered two surveys followed by a semi-structured interview and a two-hour long observation visit. Survey data was analyzed to determine the daily activities performed by research coordinators, the tools they use to complete the activities and their satisfaction with the current systems available to perform those tasks. The coordinator’s satisfaction with the current processes was also assessed. The interviews were transcribed and coded using the grounded theory methodology to identify important themes related to unmet needs and IT adoption. Observations were used to provide supplementary data.Results: Systematic analysis reveals that research coordinators are over burdened with mostly paper-based tasks leading to redundancy and inefficiency. There is a lack of appropriate systems, tools and infrastructure to support clinical research. Considerable individual, site and industry-related barriers will have to be overcome to achieve a vision of connected communities engaged in clinical research.8. OpenClinica 2.0 - Using Open Source in Clinical ResearchPresenter: Cal Collins, CEOOrganization: Akaza ResearchContact: ccollins@, phone: 617-621-8585 x 11, FAX: 617-621-0065 Topics: Multi-center trial infrastructure; Interoperability strategies; Sharing clinical research data; User tools: collecting and storing dataABSTRACTAs clinical research becomes more informatics intensive organizations are beginning to look towards open source to meet the challenges of flexibility, and interoperability, and cost. In the search for low-cost, adaptable technologies to enhance clinical and translational research, open-source software is being embraced by government, academia, and the private sector to drive and accelerate discovery. Open-source solutions are sustained by developer communities and also by commercial vendors who promote agility and choice while easing concerns about data availability, lock-in, interoperability, and regulatory compliance.OpenClinica is an open source software (OSS) platform for clinical data capture and trial management. The OpenClinica stakeholder community drives innovation, identifies priorities, and sustains rapid development while keeping the platform at low cost. Commercial backing for the platform provides functions for quality management and regulatory compliance within the framework of ICH Good Clinical Practice (GCP) guidelines and FDA 21 CFR Part 11 regulations on electronic records.Open Source Software provides an innovative way to address many of the complex challenges of data management, compliance, and interoperability in the modern clinical research environment. OSS developed under a collaborative development model can drive the adoption of standards that can cost-effectively enable interoperability in clinical and translational research, particularly in smaller facilities. The paradigm encourages innovation, risk taking, transparency, and collaboration in development.In this poster, we look at how current OpenClinica 2.0 development activities are leading to reduced costs and driving innovation in areas such as:- Automated data exchange with other systems in the healthcare and clinical research enterprises - Efficiencies in electronic data capture (EDC) using common data element libraries, semantically harmonized domain models and vocabularies, and messaging interfaces- Improving research management and monitoring- Integration of research data across distributed heterogeneous data sources.- Collaborative community development teaming commercial, government, and academic informatics professionals developing on a common open platform- Enabling fully standards-based clinical trial management operations9. Secondary Use of Health Data to Support Evidence-Based Study DesignPresenter: Charles Barr, Therapeutic Area DirectorOrganization: Roche Laboratories IncContact: charles_e.barr@, phone: 973-562-3158Topic: Secondary use of clinical data for researchOther authors: Deborah Marshall and William CrownABSTRACTGiven the high level of investment in clinical trials, both in terms of time and expense, there has been a movement towards establishing data standards for clinical trials that has been estimated to generate considerable savings to the industry. In a similar manner, the secondary use of health data can assist in the planning and implementation of clinical trials and post-launch economic studies to increase the likelihood of successful study results, which critically affect the future of the drug product.“Real world” health data have the advantages of large sample sizes and represent a broad range of patients. For example, by applying the proposed inclusion and exclusion criteria of clinical trials to large retrospective databases, one can assess whether there are enough patients with the condition of interest to enable the trial to be conducted, the statistical power to detect differences in clinical and economic outcomes, where the patients are located geographically, and their profiles in terms of medical comorbidities, concomitant medications, demographics, and health care expenditures, expected enrollment rate and appropriate length of follow up, as well as the profile of physician specialties treating the patients. Trials that focus on the collection of health economic data present a number of unique challenges – for example, health care expenditure data tend to be highly skewed, which generally requires that health economic trials be substantially larger than efficacy trials.This session will describe the kinds of secondary health data available and how these data can be applied to expedite and enhance the planning and design of clinical and health economic research trials through simulation models. We will then discuss metrics for evaluating the impact of these data on key business processes and outcomes. Finally, we will build a business case study evaluating the potential ROI for evidence-based design of clinical and health economic research with secondary use of health data.10. A Contact Registry for Persons with Rare Diseases: A Tool for Recruiting and RetainingPresenter: Rachel Richesson, Assistant ProfessorOrganization: University of South FloridaContact: richesrl@, phone: 813-396-9522, FAX: (813) 396-9601Topic: Recruitment for clinical researchOther authors: Ken Young, Jamie Malloy, Heather Guillette, Jeffrey KrischerABSTRACTa) Objective: The Rare Disease Clinical Research Network (RDCRN) consists of 10 clinical research consortia and a central Data and Technology Coordinating Center (DTCC). The RDCRN supports many studies in diverse and rare diseases, and tools and methods that enhance recruitment and retention are particularly valuable in this network.b) Methods: The DTCC maintains a registry of patients who self-identify with a particular diagnosis and express a willingness to be contacted by the RDCRN to enroll in clinical studies. The registry is compliant with the Health Insurance Portability and Accountability Act (HIPAA). To protect the privacy of those in the registry, identifying information is not shared with individual investigators. Rather, RDCRN investigators use the DTCC as a vehicle to push information to potential research subjects on disease treatment updates and upcoming trials.c) Results: As of October 2006, over 2,700 individuals representing over 40 different rare diseases were enrolled in the RDCRN Contact Registry. This high number of rare disease registrants is impressive considering that the network is new, opened first research protocols to enrollment in March 2006, and has undertaken no formal marketing. Most of the registry enrollees to date joined via the Internet, although in February 2006 the RDCRN Contact Registry began allowing individuals to enroll by mail or by telephone. These individuals overwhelmingly prefer to be contacted about future studies via email (68%) versus mail (15%) or telephone (15%). This poster and demonstration will outline strategies for maintaining valid contact information and for sustaining the interest of those enrolled. Updated data on the number and characteristics of individuals registered will be presented.d) Conclusions: The Contact Registry offers a means to accumulate potential study participants and has the potential to increase participation in RDCRN studies.11. An Infrastructure for Conducting Clinical Trials in Primary CarePresenter: Stuart Speedie, ProfessorOrganization: University of MinnesotaContact: speed002@, phone: 612-624-4657, FAX: 612-6264200Topics: Clinical trial protocol authoring and management tools, Multi-center trial infrastructure, Practice-based research networks, Interoperability strategies, Recruitment for clinical research, User tools: collecting and storing dataOther authors: Theodoros N. Arvanitis, Kevin A. Peterson, Brendan Delaney, Ida Sims ABSTRACTThe electronic Primary Care Research Network (ePCRN) is an NIH Roadmap funded project designed to explore the feasibility of conducting clinical trials in the community – specifically in primary care settings. It is a collaboration of investigators from the University of Minnesota, University of Birmingham (UK), University of California, San Francisco and 12 primary care research networks across the US. These research networks consist of groups of primary care practices that have administratively organized for the purpose of conducting research studies. The ePCRN electronically links a variety of primary care practices from these research networks and facilitates secure communication with those practices. Therefore, such communication protects the privacy and confidentiality of the patient. In its present physical form, the system consists of a highly secure Citrix computing environment that requires the combined use of an RSA-based token and password for access. The ePCRN consists of three primary components: a trialist’s workbench for designing clinical trials, a clinical trials management system for conducting and managing clinical research studies and a translation system of research into practice component. The workbench allows an investigator to formulate and test eligibility criteria for feasibility by anonymously identifying the numbers of eligible patients within the practices that are members of the network. It facilitates simulation of various research designs through a similar mechanism. Once a design is finalized and approved, the same system can be used to notify the practices that specific patients are eligible for the study and should be targeted for recruitment. After a patient has been recruited and met eligibility criteria, they are enrolled in the clinical trials management system (CTMS) and proceed through the planned study under the supervision of that system. One simple trial with 100 participating physicians has been successfully conducted to test the feasibility of the system. The ePCRN project will provide the necessary infrastructure to meet the NIH Roadmap goal of expanding and extending the conduct of clinical trials into community settings, by promoting and facilitating the use of primary care research networks for that purpose.。